Senior QA Specialist, Change Management
Arrowhead Pharmaceuticals
August 17, 2026
Remote friendly (Madison, WI)
United States
Operations
The Position (Senior QA Specialist, Quality Assurance)
Supports the QMS change management process for Arrowhead’s preclinical, clinical, and commercial programs, including change control activities, related risk assessments, and verification of effectiveness.
Responsibilities:
- Support QMS change control system components (review, process, and disposition change requests for completeness, accuracy, and procedural compliance).
- Coordinate and support Change Control Board (CCB) meetings (agenda, minutes, and follow-up to closure).
- Support cross-functional impact assessments; confirm action plans and effectiveness checks.
- Partner in risk assessment activities to identify, evaluate, and document quality/compliance risks.
- Maintain and update CCB schedules and dashboards.
- Perform quality review and disposition of change controls/effectiveness checks for accuracy, completeness, and regulatory alignment prior to approval escalation.
- Compile metrics and prepare reports for review boards and annual product quality reviews.
- Train and coach stakeholders on QMS change management processes.
- Support internal audits, regulatory inspections, and third-party audits as a subject matter resource.
- Drive continuous improvement of QMS change management processes and workflows.
- Write/review/change control/issue/organize procedural documents (policies, SOPs, work instructions, forms) using existing templates.
- Additional duties as assigned.
Requirements:
- Bachelor’s degree in a science discipline (or equivalent).
- 5+ years in a regulated environment; preference for QA, change management, and/or risk management.
- Working knowledge of FDA, EU, and ICH GxP regulations and guidance.
- Excellent written/verbal communication; effective with internal/external parties.
- Ability to coordinate cross-functional activities and drive tasks to completion.
- Proficiency with Microsoft Word, Excel, and Smartsheet.
Preferred:
- Independent work; manage priorities in a fast-paced environment.
- Experience with GMP-supporting quality systems (21 CFR Parts 11, 210, 211, QMSR, EU GMP).
- Prior use of an electronic document and quality management system in a regulated environment.
Wisconsin pay range: $90,000–$110,000.
Candidates must have current, valid authorization to work in the country where this role is located.
Supports the QMS change management process for Arrowhead’s preclinical, clinical, and commercial programs, including change control activities, related risk assessments, and verification of effectiveness.
Responsibilities:
- Support QMS change control system components (review, process, and disposition change requests for completeness, accuracy, and procedural compliance).
- Coordinate and support Change Control Board (CCB) meetings (agenda, minutes, and follow-up to closure).
- Support cross-functional impact assessments; confirm action plans and effectiveness checks.
- Partner in risk assessment activities to identify, evaluate, and document quality/compliance risks.
- Maintain and update CCB schedules and dashboards.
- Perform quality review and disposition of change controls/effectiveness checks for accuracy, completeness, and regulatory alignment prior to approval escalation.
- Compile metrics and prepare reports for review boards and annual product quality reviews.
- Train and coach stakeholders on QMS change management processes.
- Support internal audits, regulatory inspections, and third-party audits as a subject matter resource.
- Drive continuous improvement of QMS change management processes and workflows.
- Write/review/change control/issue/organize procedural documents (policies, SOPs, work instructions, forms) using existing templates.
- Additional duties as assigned.
Requirements:
- Bachelor’s degree in a science discipline (or equivalent).
- 5+ years in a regulated environment; preference for QA, change management, and/or risk management.
- Working knowledge of FDA, EU, and ICH GxP regulations and guidance.
- Excellent written/verbal communication; effective with internal/external parties.
- Ability to coordinate cross-functional activities and drive tasks to completion.
- Proficiency with Microsoft Word, Excel, and Smartsheet.
Preferred:
- Independent work; manage priorities in a fast-paced environment.
- Experience with GMP-supporting quality systems (21 CFR Parts 11, 210, 211, QMSR, EU GMP).
- Prior use of an electronic document and quality management system in a regulated environment.
Wisconsin pay range: $90,000–$110,000.
Candidates must have current, valid authorization to work in the country where this role is located.